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Entry into a Material Definitive Agreement

On June 16, 2021, Ocuphire Pharma, Inc. ("Ocuphire") reported that entered into a License Agreement (the "License Agreement") with Processa Pharmaceuticals, Inc. ("Processa"), pursuant to which Ocuphire granted Processa an exclusive license to develop, manufacture and commercialize RX-3117 globally, excluding China (Filing, 8-K, Rexahn, JUN 16, 2021, View Source [SID1234584277]).

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As consideration for the License Agreement, Ocuphire will receive 44,689 shares of Processa common stock and a $200,000 cash payment. As additional consideration, Processa will pay Ocuphire development and regulatory milestone payments upon the achievement of certain milestones, which primarily consist of dosing a patient in pivotal trials or having a drug indication approved by a regulatory authority in the United States or another country. In addition, Processa must pay Ocuphire one-time sales milestone payments based on the achievement during a calendar year of one or more thresholds for annual sales for products made and pay royalties based on annual licensing sales. Processa is also required to give 32% of any milestone payments received to Ocuphire based on any sub-license agreement it may enter into with respect to the Licensing Agreement.

Processa is required to use commercially reasonable efforts, at its sole cost and expense to oversee such commercialization efforts, to research, develop and commercialize products in one or more countries, including meeting specific diligence milestones that consist of: (i) first patient administered drug in a clinical trial of a licensed product prior to the three (3) year anniversary of the effective date; and (ii) first patient administered drug in a pivotal clinical trial of a licensed product or first patient administered drug in a clinical trial for a second indication of a licensed product prior to the five (5) year anniversary of the effective date. Either party may terminate the agreement in the event of a material breach of the agreement that has not been cured following written notice and a 120-day opportunity to cure such breach, and Processa may terminate the agreement for any reason upon 120 days prior written notice to Ocuphire.

Positive survival data for Novartis investigational radioligand therapy 177Lu-PSMA-617 published in The New England Journal of Medicine

On June 23, 2021 Novartis reported that VISION data published in The New England Journal of Medicine (NEJM) shows that 177Lu-PSMA-617 plus standard of care (SOC) significantly improved both overall survival (HR = 0.62 [95% CI: 0.52−0.74]; P<0.001; median 15.3 vs 11.3 months) and imaging-based progression-free survival (HR = 0.40 [99.2% CI: 0.29−0.57]; P<0.001; median, 8.7 vs 3.4 months) versus SOC alone in patients with progressive PSMA-positive mCRPC1 (Press release, Novartis, JUN 23, 2021, View Source [SID1234584276]). VISION data were first presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 6 (see media release).

"We are proud of these data showing that 177Lu-PSMA-617 can significantly shrink tumors and extend life for patients with prostate cancer, who have been heavily pre-treated and currently have limited treatment options," said Jeff Legos, Global Head of Oncology Development, Novartis. "We believe that radioligand therapy with 177Lu-PSMA-617 has great potential to improve outcomes in advanced prostate cancer and have already started two new Phase III studies in earlier lines of treatment."

Other data highlighted in the publication and ASCO (Free ASCO Whitepaper) presentation:

Median time to first symptomatic skeletal event or death was 11.5 months in the 177Lu-PSMA-617 plus SOC arm versus 6.8 months in the SOC only arm (P<0.001; α=0.05; HR = 0.50 [95% CI: 0.40, 0.62])1
Overall response rate in patients with measurable or non-measurable disease at baseline was 29.8% partial or complete response in the 177Lu-PSMA-617 plus SOC arm compared to 1.7% partial response in the SOC only arm (two-sided p-value: <0.001)1
The incidence of grade ≥3 treatment-emergent adverse effects was 52.7% in the 177Lu-PSMA-617 plus SOC arm vs 38.0% in the SOC only arm1
Serious drug-related treatment emergent adverse events occurred in 9.3% of patients in the 177Lu-PSMA-617 plus SOC arm compared to 2.4% in the SOC only arm2
Two additional studies with 177Lu-PSMA-617 radioligand therapy in earlier lines of treatment for metastatic prostate cancer are ongoing, investigating potential clinical utility in the mCRPC pre-taxane setting (PSMAfore) and in the metastatic hormone-sensitive setting (PSMAddition). Novartis is also evaluating opportunities to investigate 177Lu-PSMA-617 radioligand therapy in earlier stages of prostate cancer.

The NEJM publication is available online at www.NEJM.org

About 177Lu-PSMA-617
177Lu-PSMA-617 is an investigational PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer. It is a type of precision cancer treatment combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle)3-5. After administration into the bloodstream, 177Lu-PSMA-617 binds to prostate cancer cells that express PSMA6, a transmembrane protein, with high tumor-to-normal tissue uptake3,7,8. Once bound, emissions from the radioisotope damage tumor cells, disrupting their ability to replicate and/or triggering cell death9-11. The radiation from the radioisotope works over very short distances to limit damage to surrounding cells1,3,7.

About VISION
VISION is an international, prospective, randomized, open-label, multicenter, phase III study to assess the efficacy and safety of 177Lu-PSMA-617 (7.4 GBq administered by intravenous infusion every 6 weeks for a maximum of 6 cycles) plus investigator-chosen standard of care in the investigational arm, versus standard of care in the control arm1. Patients with PSMA PET-scan positive mCRPC, and progression after prior taxane and androgen receptor pathway inhibitors, were randomized in a 2:1 ratio in favor of the investigational arm1. The alternate primary endpoints were rPFS and OS1. The study enrolled 831 patients1.

Microbiotica’s Live Bacterial Therapeutic, MB097, in development to begin clinical trials in 2022 in immuno-oncology

On June 23, 2021 Microbiotica, a leading player in microbiome-based therapeutics and biomarkers, reported that MB097 is now in pre-clinical development for treatment of patients not responding to anti-PD1 therapy (Press release, Microbiotica, JUN 23, 2021, View Source [SID1234584275]). Clinical trials are due to begin in 2022. MB097 is clinically designed and experimentally validated.

Studies have shown that the gut microbiome plays a critical and causative role in determining which cancer patients respond to Immune Checkpoint Inhibitor (ICI) therapy. However clinical translation of this ground-breaking discovery has been hampered by large inconsistencies between studies in the intestinal bacteria associated with anti-PD1 efficacy. The Microbiotica platform is unrivalled in the comprehensiveness and precision by which it can profile the microbiome of patients. It has enabled the Company to identify the first microbiome signature predictive of response to ICI therapy across four independent melanoma studies, by analysing MELRESIST, a melanoma study conducted in collaboration with Cambridge University Hospitals. This microbiome signature is a highly predictive clinical biomarker in advanced melanoma and is also predictive in non-small cell lung cancer (NSCLC).

The bacteria most significantly linked to outcome are all elevated in patients that respond to anti-PD1 based therapy, suggesting that gut microbes drive ICI efficacy by enhancing the anti-tumour immune response. MB097 is a Live Bacterial Therapeutic (LBT) comprising nine key species from the signature, and is being developed as a co-therapy with ICI in advanced melanoma and NSCLC. MB097 has shown potent anti-tumour efficacy in a mouse syngeneic tumour model. The bacteria also demonstrate multiple immuno-stimulatory mechanisms in primary human immune cell assays, leading to Cytotoxic T Lymphocyte activation and tumour cell killing in vitro.

Clinical testing of MB097, in combination with anti-PD1, will begin in 2022 with a Phase 1b study conducted in the same melanoma patient population that the microbiome signature was derived from. This is precision medicine enabled by the precise microbiome profiling of Microbiotica’s platform.

ICIs have transformed oncology, having increased the range of cancers that can be treated as well as improving levels of efficacy, including complete remission in some cases. However, response rates tend to be low, typically in the range 10%-40% of patients. Consequently, there is a major unmet need for co-therapies to increase the number of responders and for biomarkers to stratify patients for treatment.

Mike Romanos, Co-founder and CEO, Microbiotica, said:

"Immune Checkpoint Inhibitors have had a major impact on the lives of many cancer patients, however fewer than half respond to this type of immunotherapy. This has driven us to design a microbiome therapeutic to improve patient response rate. Through our MELRESIST study data and our platform, we have been able to identify a consistent bacterial signature predictive of drug response in advanced melanoma and NSCLC.

"The Live Bacterial Therapeutic, MB097, arising from this signature, aims to tap into this predictive signature of ICI therapy response. Preclinical in vivo data and mechanistic in vitro human cell data generated thus far have been hugely encouraging. Coupled with our ongoing collaboration with Cancer Research UK and Cambridge University Hospitals, our IO program is now a significant focus for the Company going forward. The aim is for us to enter the clinic in 2022 with this programme."

Microbiotica’s platform comprises the world’s leading Reference Genome Database and Culture Collection of gut bacteria, and an unrivalled capability to culture and characterise all gut bacteria from patients at scale. This is complemented by a suite of bioinformatic and machine learning tools that enable the identification of previously undetectable gut bacterial signatures linked to patient phenotype.

Jounce Therapeutics Provides Update on INNATE Study and Discovery Pipeline Expansion, and Provides a Portfolio Update at 2021 R&D Day

On June 23, 2021 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported a comprehensive update on its discovery and clinical-stage pipeline at its 2021 virtual R&D Day (Press release, Jounce Therapeutics, JUN 23, 2021, View Source [SID1234584273]). Presentations will highlight Jounce’s productive discovery engine and platform, updates on its discovery pipeline, and progress on the clinical development of JTX-8064. In addition to presentations from Jounce management and scientific team members, key opinion leader and one of Jounce’s scientific founders, Robert Schreiber, Ph.D., Distinguished Professor of Pathology and Immunology at The Washington University School of Medicine, will discuss the scientific rationale for targeting myeloid cells and the therapeutic potential of re-programming macrophages through inhibition of LILRB2.

"Jounce is at an exciting time in its life cycle and I am incredibly pleased to have the opportunity to share the latest developments on our discovery and clinical stage pipelines, while also sharing a look into our productive and validated Translational Science Platform. More specifically, we will discuss the monotherapy dose escalation status of our INNATE trial of JTX-8064. Thanks to a high level of investigator engagement and dedicated efforts from our team, the timing of expansion cohort initiations is now expected in the third quarter of this year," said Richard Murray, Ph.D., Chief Executive Officer and President of Jounce Therapeutics. "Our pipeline has been built to bring forward new biomarker-enabled immunotherapies to address the evolving unmet needs of cancer patients, whose tumors may be sensitive or resistant to today’s approved immunotherapies."

"One of the key attributes of Jounce’s approach to immuno-oncology is its expertise in developing molecules that target a diverse set of immune cell types within the tumor microenvironment. Through the work of our platform, we have a greater understanding of how immune suppressive macrophages and LILRB2 itself can serve as negative prognostic indicators in several tumor types," said Dmitri Wiederschain, Ph.D., Chief Scientific Officer of Jounce Therapeutics. "We believe that the LILRB family represents attractive immuno-oncology targets with the potential to improve upon and restore responsiveness to PD-(L)1 inhibitors. As such, we are pleased to announce that we are rapidly advancing two additional LILRB family programs through discovery, targeting LILRB1 and LILRB4."

R&D Day Presentation Highlights Include:

Utilization of Jounce’s Translational Science Platform to investigate the tumor microenvironment and identify cell type-specific targets with unique biology
Overview of differentiated biomarker approach from discovery through development
Introduction of new discovery programs focused on additional LILRB family members, including LILRB1 and LILRB4
Update on monotherapy dose escalation and receptor occupancy from the INNATE clinical trial of JTX-8064
Announcement of timing of INNATE clinical trial monotherapy and pimivalimab combination expansion cohort initiation, expected in the third quarter of 2021
Update on continued progress on Jounce’s first biomarker patient selection study, SELECT
Anticipated Milestones:

JTX-8064 (INNATE):
Establish recommended Phase 2 dose
Initiate tumor-specific monotherapy and pimivalimab combination expansion cohorts beginning in the third quarter of 2021
Vopratelimab (SELECT):
Patient enrollment to support clinical data in 2022
Continue to advance multiple new targets through discovery pipeline with goal of an investigational new drug (IND) every 12-18 months
Webcast Details:
A webcast of the R&D Day will be available by visiting "Events and Presentations" in the Investors and Media section of Jounce’s website at www.jouncetx.com. A replay of the webcast will be available for 30 days following the presentation.

Bulletin from Annual General Meeting in Isofol Medical AB (publ) held on June 23, 2021

On June 23, 2021 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), reported that held its annual general meeting ("AGM") at which the following principal resolutions were passed (Press release, Isofol Medical, JUN 23, 2021, View Source [SID1234584272]).

Adoption of income statement and balance sheet for the financial year 2020 and discharge from liability
The AGM resolved to adopt the income statements for the financial year 2020 as well as the balance sheets as of 31 December 2020, as set out in the annual report for the Company and the group. The members of the Board of Directors and the managing director were discharged from liability for the financial year 2020.

Allocation of profit or loss
The AGM resolved, in accordance with the Board of Directors’ proposal, that no dividend shall be paid for 2020 and that the results of the Company shall be carried forward.

Election of board members, auditors, fees to the Board of Directors and auditors
The AGM resolved, in accordance with the nomination committee’s proposal, that the number of members of the Board of Directors shall be eight without deputies and that the number of auditors shall be one registered accounting firm.

In accordance with the nomination committee’s proposal Lennart Jeansson was elected as new member of the Board of Directors and Alain Herrera, Anna Belfrage, Aram Mangasarian, Magnus Björsne, Paula Boultbee, Pär-Ola Mannefred and Robert Marchesani were re-elected as members of the Board of Directors, all for the period until the end of the next AGM. Pär-Ola Mannefred was re-elected as the chairman of the Board of Directors.

The audit firm KPMG AB was re-elected as auditor of the Company, with Jan Malm as auditor-in-charge, for the period until the end of the next AGM.

The AGM further resolved to, in accordance with the nomination committee’s proposal, that fees to the chairman of the board shall be paid with SEK 550,000, to members of the board who are not employed within the Company with SEK 250,000, to the chairman of the audit committee with SEK 75,000, to each of the other members of the audit committee with SEK 40,000, to the chairman of the remuneration committee with SEK 50,000 and to each of the other members of the remuneration committee with SEK 25,000.

The AGM further resolved, in accordance with the nomination committee’s proposal, that board members that board members (in addition to remuneration for expenses relating to travel and accommodation) domiciled in Europe, but outside the Nordic countries, shall receive a remuneration of SEK 7,500 per physical board meeting and board members domiciled in North America shall receive a remuneration of SEK 15,000 per physical board meeting.

The AGM further resolved, in accordance with the nomination committee’s proposal, that the remuneration to the auditor of the Company shall be paid in accordance with approved statement of costs.

Principles for the appointment of the nomination committee
The AGM resolved, in accordance with the nomination committee’s proposal, that the principles for appointment of a nomination committee as adopted at the annual general meeting 2020 and as presented in the convening notice would remain unchanged.

Approval of the Board of Directors’ remuneration report
The AGM resolved, in accordance with the proposal from the board of directors, to approve the remuneration report for the financial year 2020.

Amendment of the articles of association
The Board of Directors’ proposal to amend the articles of association did not achieve the required majority, hence, the proposal was not adopted by the AGM.

Authorisation for the Board of Directors to resolve on issues
The Board of Directors’ proposal regarding issue authorisation to the Board of Directors, did not achieve the required majority, hence, the proposal was not adopted by the AGM.

The information was submitted for publication, through the agency of the contact person set out above, at 18:10 CEST on June 23, 2021.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate that is developed to improve the efficiency of 5-FU based (folate-based) chemotherapy primary for advanced colorectal cancer. Arfolitixorin is currently being evaluated in a global phase III-study, AGENT. Arfolitixorin is the active end product of extensively used folate-based drugs and can potentially benefit all patients with advanced colorectal cancer, as arfolitixorin does not require metabolic activation to become effective.